Observation on the Clinical Efficacy of Shenkangling in the Treatment of Renal Ischemia-reperfusion Injury (Kidney Deficiency and Blood Stasis Syndrome)

1. Study Design and Methods 1.1 Research Method A multicenter, open-label study design is employed. 1.2 Source of Participants Clinical observation cases are from patients with ischemia-reperfusion injury caused by partial nephrectomy or renal exploration, admitted between March 2025 and December 2026 to the Department of Urology at Zhejiang University School of Medicine Fourth Affiliated Hospital and Fujian University of Traditional Chinese Medicine Affiliated People's Hospital. A total of 100 subjects are included.

1.3 Participant Selection and Exclusion Criteria 1.3.1 Western Medicine Diagnostic Criteria

1. Partial nephrectomy due to renal tumor: Based on the "Chinese Expert Consensus on Laparoscopic and Robotic Partial Nephrectomy for Renal Tumors," the general diagnosis of renal tumor should be met, with the maximum tumor diameter ≤ 4 cm, and the indication for partial nephrectomy.
2. Partial nephrectomy due to renal cyst: Based on the "Consensus on the Safety of Surgical Treatment for Simple Renal Cysts," the general diagnosis of renal cyst should be met, and partial nephrectomy should be indicated.
3. Partial nephrectomy or renal exploration due to renal injury: According to the "Urological Injury Diagnosis and Treatment Guidelines" issued by the Chinese Urological Association, injuries such as renal contusion, partial renal laceration, complete renal laceration, and renal pedicle injury caused by open or closed trauma, which are indications for partial nephrectomy or renal exploration.
4. Partial nephrectomy due to renal hamartomas, complex renal cysts, or other conditions: Based on the "2022 Edition of the China Urological and Andrological Diseases Diagnosis and Treatment Guidelines," the general diagnosis of these diseases should be met, and partial nephrectomy should be indicated.

1.3.2 Traditional Chinese Medicine Diagnostic Criteria

Based on clinical manifestations and the "Guidelines for Clinical Research on New Chinese Medicines" and "General Principles for Clinical Research on New Chinese Medicines" established by the People's Republic of China, and referring to the opinions of various scholars, the criteria are as follows: